Tue. Nov 30th, 2021

On Saturday 31 July, the Commission published its Decision launching the Clinical Trials Information System (CTIS), a basic IT system tool designed to apply the Clinical Trials Regulation (CTR), as of 31 January 2022.

The application will bring substantial changes to the authorisation and supervision of human research on medicinal products.

Stella Kyriakides, Commissioner for Health and Food Safety, said:

“The pandemic has clearly shown the importance of efficient clinical trials that do not compromise on rigorous safety and efficacy standards. With the Clinical Trials Regulation, we will be able to guarantee higher safety protection for participants of clinical trials, support EU-wide clinical trials, and deliver faster access to the most promising safe and effective medical products to citizens, for the COVID-19 crisis and beyond.”

The goal of the Clinical Trials Regulation is to create an environment that stimulates the establishment and undertaking of clinical trials in the EU.

At the same time, it aims to guarantee the highest standards of safety for participants of clinical trials as well as increased transparency of clinical trial information.

The Regulation makes the use of the CTIS mandatory for newly applied clinical trials. However, until 31 January 2023, applicants can still chose whether to submit their application to start a clinical trial according to the current system (Clinical Trials Directive) or according to the Clinical Trials Regulation.

From 31 January 2023 onward, submission according to the CTR becomes mandatory and by 31 January 2025, all ongoing trials approved under the current clinical trial directive will need to transition to the new Regulation.

The  Clinical Trials Information System will also, together with other EMA IT tools, support the coordinated assessment of safety reporting in the context of clinical trials and therefore contribute to the understanding of the benefits and the risks of medicinal products that are planned to enter or are already on the market of the Union.

More information on the Clinical Trials Regulation and on the Clinical Trials Information System can be found here and here.